Disclosures. Transformer Spine Surgical Consultant/ Carefusion Baxano io Flex IDE Consultant. Minimally Invasive vs. Open Spine Surgery: 6 Key Points

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1 Movement Trends Toward MIS Procedures in the Spine Including SI Arthrodesis: Business and Clinical View June 13, 2014/ Becker s Chicago Morgan P. Lorio, MD, FACS Chair, ISASS Task Force (Coding & Re-imbursement) Board Member IASP Disclosures Transformer Spine Surgical Consultant/ Carefusion Baxano io Flex IDE Consultant Minimally Invasive vs. Open Spine Surgery: 6 Key Points 1. Clinical outcomes similar between the two. 2. Overall lower costs for minimally invasive procedures. 3. Minimally invasive spine device market growing. 4. New MIS techniques now have evidence- based backing 5. Radiation exposure higher for MIS procedures 6. Goals of Open Spine Surgery remain the GOLD Standard (Author Laura Miller)

2 OP Cervical Spine Surgery Defined as Posterior Laminoforaminotomy & ACDF (currently, posterior cervical surgery remains a concern) Stieber, JR ET Al. Retrospective Medical Record Review of their own practice evolution Methods 90 Patients underwent different levels 2 control groups, used function adjunct to autogenous or structural allograft Clinical Outcomes May Not Be The Same The Spine Journal 5(2005) Outpatient Inclusion Criteria Primary procedure One or two level involvement Pre- op MRI C4/ C5 through C6/ C7 Absence of myelopathy Structural allograft Estimated operative time 2 hr Exclusion of subjectively large neck size Appropriate discharge environment Post-op X-ray The Spine Journal 5(2005) Results Combined Controls OP 7 Patients (13%) Dysphagia 3 Patients (5%) 3 Patients (10%) Graft Site Pain 4 Patients (7%) LOS 4 Patients (7%) Re-Admit 4 Patients (7%) ø/ None The Spine Journal 5 (2005)

3 Conclusions 1. No statistical difference; however, 2. OP Group had lower complication rates due to Selection bias 3. A population of patient exists for where IP surgery will always be the most appropriate option; however, many patients are suitable candidates for OP surgery 4. Airway swelling may be minimized with gentle retraction; improved ASC designed techniques and implants) Transformer Spine The Spine Journal 5 (2005) Feasibility of ACDF As An Outpatient Procedure (Trahan, J, et al) Retrospective chart review using allograft 117 patients, of which 59 patients (50%) were OP Complication rates were low (1.4%) readmission due to neck swelling No definitive guidelines RE: Selection? Query if technique, steroid administration, and routine use of drains might obviate concerns in ASC settings? Cervical Artificial Disc. On the horizon, ISASS Policy authored by Domagoj, MD, IJSS (World Neurosurgery 2011 Jan 25 (1) 145-8) Vertebral Augmentation Concepts Triaged by Health Care Concerns the top of Spine pyramid MIS Spine (Vertebroplasty/ Kyphoplasty) Vertebroplasty(s) Stable over time/ OP Kyphoplasties increased 6-fold (Due to financial incentives, predominant use by Orthopedic Surgeons, perception of safety and efficacy, and potentially greater correction of deformity) Media amplified bad news lingers flawed information: referencing 2 Studies (2009) by Buchbinder & Kalmes (Level 1 now down-graded) & AAOS Guidelines Spine Line Panel Review (2010) noted the disconnect on the above with a mountain of evidence II- IV. 2011, Ededin et. al., demonstrated higher survival rates in the operated VCF s.

4 Trends in Site Of Service Goz et. al. Vertebral Augmentation Snapshot by Specialty Goz et. al Florida Vertebroplasties Florida Kyphoplasties Goz V. et. al., Spine J 2011 Aug; 11(8): Kyphoplasty & Vertebroplasty: Trends in Ambulatory and Inpatient Setting CMS Proposed Rule (CMS P) P)-Revision to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B for r CY 2014 CPT Code Descriptor 2013 Non- Facility PE RVUs (final) Percut vertebroplasty thor Percut vertebroplasty lumb Percut kyphoplasty thor Percut kyphoplasty lumb Percut kyphoplasty addon 2014 Non- Facility PE RVUs (proposed) Percent Change percent percent percent percent percent Pimenta/ Lorio ISASS...

5 Lumbar Decompression +/- Stabilization 1. SPORT (Spine Patient Outcome Research Trial) demonstrated clear superiority of laminectomy vs. conservative 4 years 2. Parker, SL et. al., 2 yr Comp Med Management of Degen Lumbar Spine Disease cost, pain, disability, & QOL challenged the value of conservative management for , 724.0, & Kleinstück, F.S. et. al. (Spine 2009) The Influence of Preoperative Back Pain on the Outcome of Lumbar Decompression Surgery Conclusion: Overall, greater back pain relative to leg/ buttock baseline was associated with significantly worse outcome after decompression intuitive J Neurosurgery; Spine/ 2014 Trends in the Surgical Treatment of Lumbar Spine Disease, Pannell, l, W.C. et. al., The Spine Journal. Demopraphics vary regionally. CPT Occurrence per 10,000 patients Outpatient Procedure Type In Four Study States, Gray, D.T. e.t al., Population Trends in Spine Surgery, Spine 2006

6 Coflex ASC Approved BC/BS & Aetna Coflex is being CPT #22840 Coflex IDE Study 1.Coflex Interlaminar Stabilization Compared with Spinal Fusion, Davis et.al., Spine Sponylolithesis treated with Coflex Stabilization of Fusion, Davis et.al., J. Neurosurgery Spine Role of Coflex as an Adjunct to Decompression for Symptomatic Lumbar Spinal Stenosis, Kumar, N. et.al., ASJ Baxano io Flex IDE Targets Lumbar Spinal Stenosis May Obviate the Need for TLIF in Some Cases Avoids Collateral Damage MIS SIJ Fusion Methods

7 Survey Snapshot of Total Procedures and Percentages Performed Annually nually by Membership of Surveyed Organizations, ISASS and SMISS Total Procedures Open Total Open % 60.56% 50.53% 32.63% 12.15% MIS Total MIS % 39.44% 49.47% 67.37% 87.85% *Through November 11, Lorio, M.P. et.al., Utilization of MIS Approach for SIJ Fusion in Surgeon Population of ISASS & SMISS Membership, Open Orthop. J Prevalence Of Two Different Surgical Techniques In Population ISASS I and SMISS Membership Over Different Time Periods (from 2009 to 2012) Lorio, M.P. et.al., Utilization of MIS Approach for SIJ Fusion in Surgeon Population of ISASS & SMISS Membership, Open Orthop. J Incidence Rate Ratio of Open vs. MIS Techniques Over Period of 4 Years (from 2009 to 2012) 7.65 Incidence Rate Ratio 0.71 Lorio, M.P. et.al., Utilization of MIS Approach for SIJ Fusion in Surgeon Population of ISASS & SMISS Membership, Open Orthop. J

8 Analysis of Approach Patterns in Different Site of Service Lorio, M.P. et.al., Utilization of MIS Approach for SIJ Fusion in Surgeon Population of ISASS & SMISS Membership, Open Orthop. J Prevalence: SI Joint Pathology Low Back Pain Post-Lumbar/Lumbosacral Fusion 14.5% Sembrano % Bernard 1987 (1293 patients) 30% Schwarzer % Ivanov % DePalma % Ha 2008 (5 yr radiographic) SI Joint Pain: Burden of Disease Cher et al. Medical Devices: Evidence and Research 2013 Design o Assessed health state of chronic SI joint pain patients using EQ-5D, SF-36 o Comparison of two prospective clinical trials of MIS SI joint fusion (198 patients) vs. normal patients (3844) in a nationally representative USA cross-sectional survey (National Health Measurement Study, NHMS) Results patient with SI joint pain had significantly lower QOL compared to normal cohort SI Join Pain in comparison to other disabling conditions Higher COPD Coronary Heart Disease Asthma Mild Heart Failure Roughly Equivalent Chronic depression Severe COPD Slightly Less Lumbar stenosis Severe Parkinson s Disease 24

9 Diagnostic Algorithm for SI Joint Pain History Physical Exam Provocative Tests Diagnostic Injections Evaluation MUST include Hip Lumbar Spine SI Joint Significant Positive Clinical Response? YES NO Other possible pain generator; Continue workup Treatment Options Medication(s), PT, SIJ Injections, RF Denervation, MIS SI Joint Fusion 25 SI Joint vs. Lumbar Spine vs. Hip What role does the hip play in the diagnosis of spine and SI Joint problems? Who are these hip patients and how do we diagnose them? How can we determine which pathology is the primary pain generator? 26 Diagnosis: SI Joint Pathology Study Description Results/Conclusion Szadek J Pain 2009 Laslett Man Ther 2005 Dreyfuss J Am Acad Orthop Surg 2004 Systematic Review of 18 studies. Objective: diagnostic validity by IASP criteria 48 patients. Objective: diagnostic power of provocative tests (indiv & combo) Review article. Covers everything: anatomy, biomechanics, diff diag, etc. 5 key provocative tests 3 of 5 must be positive 1 of the 3 positive must be Thigh Trust or Compression Sensitivity = 85% Specificity = 76% Composites have value 3 or more of 6 2 of 4 in relation to injection blocks Sensitivity = 91% Specificity = 78% SIJ can be a source of LBP or buttock Can be confirmed by imagineguided injections 27

10 SI Joint Treatment Continuum Treatment Intensity Medications (NSAIDS, opiates, etc.) External Support (SI Joint Belt) Radiofrequency Ablation Physical Therapy Therapeutic SI Joint Injections (anesthetic & steroids) Conservative Care MIS SI Joint Fusion Open SI Joint Fusion Surgery (Only after failing Conservative Care) 28 Conservative Care Evidence Treatment Medication Management Evidence Often ineffective Expensive side effects Does not address underlying condition No data to support short-term or long-term treatment Physical Therapy No evidence of effectiveness Wide practice variation No systematic reviews evaluating effectiveness Steroid Injections Systematic reviews RCTs Hansen 2102, Rupert 2009 Poor evidence for peri-articular injections of local anesthetic, steroid, or botulinum toxin RF Ablation RCTs Cohen 2008, Patel 2008 The duration of benefit seems to be constrained by nerve regeneration between 6 months and one year 29 Open SI Joint Fusion History Smith-Petersen 1926 Campbell 1927 Gaenslen 1927 Bloom

11 Open SI Joint Fusion Often used to treat tumor, trauma, or infection Description 8-inch incision Dissect muscle bone Split SI joint Decorticate joint (remove joint materials) Disadvantages Large incision Substantial disruption / destruction of soft tissues and joint Large amount of blood loss Prolonged recovery (weeks before ambulation) Optional: Harvest bone graft from distant site (second surgical incision) Place hardware in joint or around joint (rods, screws, plates) Close 31 Minimal Evidentiary Support for Open SI Joint Fusion Article Year Pts TB Results Wheeler non TB 100% return to full function Gaenslen TB 78% complete improvement Smith Peterson TB 76% complete relief Mixed Uniformly good results non TB 85% success Verral TB 50% success, 2 lost to follow-up Channdler Mixed 71% complete relief Phelps and Lindsy non TB 100% complete relief Campbell TB 71% complete relief Mixed 58% complete relief Harris TB 70% complete relief Mitchell non TB 53% complete relief Avila TB 71% complete relief De La Sierre Cano TB Uniformly good results Roaf, Kirkaldy Willis 1959? TB Bukalim TB 75% good results Total Recent Evidence Mixed for Open Published Clinical Evidence 12 Articles Describe a wide variety of procedures o Fibular allograft dowels o Screws, rods, plates o Anterior/posterior exposure All retrospective case series Total of 261 patients Mixed results Fusion Article Pts Results McGuire Good pain relief; Fusion = 89.5% Kibsgard Schutz Buchowski yr = 48% good, 28% poor, 24% fair; No sig diff in ODI, VAS, SF-36 between surgery and non-surgery. LOS 25.2 days; Satisfaction = 18%; Fusion = 35% LOS 5.2 days; SF-36 sig improve; 60% would do surgery again. Giannikas Pain relief in 4 out of 5 Belanger Berthelot All fused, returned to work, satisfied. All returned to work, pain relief, satisfied Guner LOS 10 days, fused, pain free Moore % success. Keating Pain decreased, improved work status. Waisbrod % (11/21) satisfactory results. Rand Pain relief, normal activity, fused. 33

12 Typical Open SI Joint Fusion Study Buchowski 2005 Design o 20 pts from treated at Johns Hopkins o Retrospective, single-center Results o EBL: 290 cc o LOS: 5.2 days o Fusion seen on plain radiograph in yr o 60% patient satisfaction rate o SF-36 improvement (75% questionnaire completion rate) Complications o 3 (15%) revisions o 2 (10%) deep wound infections o 1 (5%) painful hardware Strengths o Detailed description Weaknesses o No protocol, unclear how patients were selected o Unknown # patients excluded (bad outcomes excluded?) o No monitoring or source verification o No prospective study definitions of fusion o No pre-defined hypotheses / stats 34 Key MIS SI Joint Fusion Articles Article N Design Results Product Level IIb Duhon Med Device Evid Res (safe & eff) 32 (outcomes) (SIFI), Prospective, multi-center, 6-mo interim results Improvement in pain, back function (ODI) and QOL (SF-36, EQ-5D) Post Long Schroeder Hosp Fusion Spec Surg J Retrospective, single-center, spine deformity adults w/prior longfusion; post-op MIS SIJ fusion ODI, & scoliosis questionnaire Improvement in back & leg pain, results, 4-15 mo (10-avg) Gaetani - J Neurosurg Sci Retrospective, single-center, 8-18 mo f/u. Improvement in pain, back function (ODI) and QOL (SF-36) Open vs. MIS Graham Smith Ann Surg Innov Res Open 114 MIS Retrospective, Open vs. MIS, 24- mo f/u MIS significantly better than open Open vs. Mason Eur Spine J Prospective, single-center, 36-mo avg f/u Improvement in pain, QOL, and pelvic specific questionnaire Bone substitute filled screws Endres Indian J Orthop Prospective analysis, single center, 13.2 mo f/u (6-24) Improvement pain and ODI DIANA cage into SIJ Cummings - Ann Surg Innov Res Retrospective, single-center, 12- mo f/u. Improvement in pain and back function Sachs - Adv Orthop Retrospective, single-center, 12- mo f/u. Improvement in pain 35 Key MIS SI Joint Fusion Articles (cont.) Article N Design Results Product Safety Miller - Med Dev Evid Res Retrospective analysis, complaint database 4/2009 1/2013 Low overall complaint and revision rate Rudolf - Open Orthop J Retrospective, single-center, compares outcomes of patients with and without prior lumbar fusion, 24-mo f/u. Significant pain reduction in all groups, but no prior fusion better Sachs - Ann Surg Innov Res Retrospective, single-center, 12-mo f/u. Improved pain, high patient satisfaction McGuire Evid Based Spine Care J Retrospective, single-center, 40-mo mean f/u. Improvement in pain, most achieved fusion Allograft dowels longitudinall y in SIJ Rudolf - Open Orthop J 2012 Khurana JBJS Br 2009 Wise J Spinal Disord Tech 2008 Al-khayer J Spinal Disord Tech Retrospective, single-center, 24-mo f/u. Prospective, single-center, 17-mo mean f/u. Prospective, single-center, 24-mo f/u. Retrospective, single center, 12-mo f/u. Rapid & sustained (mean 40mo f/u) improvement in pain, high patient satisfaction Improved QOL and pelvic scores Improvement in pain, fusion at 6mo shown by CT Improvement in pain and ODI Hollow screws across SIJ Threaded cages packed with BMP Hollow modular screws 36

13 Pain Relief: Rapid & Sustained 37 Duhon Med Devices Evid Res 2013 Safety and Midterm Effectiveness of Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study Multi-center, prospective, single-arm study (SIFI NCT ) 23 sites 94 patients (32 in Effectiveness cohort, 94 in Safety cohort) Measure VAS SIJ pain Baseline (n=32) Mo 6 Change P-value* (n=24) <.0001 ODI <.0001 EQ5D SF-36 Satisfaction PCS MCS % somewhat or very % might or definitely have again (85%) 22 (85%) * Repeated measures analysis of variance (VAS, ODI, SF-36) or t test (EQ5D). A dash indicates not required in protocol. Level IIb Schroeder Hospital Spec Surg J 2013 Post Long Fusion Early Results of Sacro Iliac Joint Fixation Following Long Fusion to the Sacrum in Adult Spine Deformity Retrospective, single center, patients who underwent a percutaneous fixation of the SIJ after corrective scoliosis surgery 6 patients (10 procedures) Mean follow-up months (range 15-4 months) Measure Baseline Post-op P-value* VAS Leg Pain < VAS Back Pain < ODI SRS22 (Scoliosis Research Society 22 questionnaire)

14 Open versus Minimally Invasive Sacroiliac Joint Fusion: A Multi-Center Comparison of Perioperative Process Measure and Clinical Outcomes Multi-center comparative retrospective cohort study 7 sites (3 Open, 4 MIS) 263 patients (149 Open, 114 MIS) Open vs. MIS Graham Smith Ann Surg Innov Res 2013 Perioperative Measures Open N Mean N Mean MIS p-value OR time < EBL (ml) < LOS (days) < VAS Pain Outcomes Open MIS N Mean Δ N Mean Δ Baseline month* month* *p< for difference 40 Why Retrospective Comparative Cohort? Few open SI joint fusion procedures performed study limitations made conducting prospective RCT comparing MIS vs. Open difficult, thus retrospective comparative cohort studies are the highest evidence available. Open SI joint fusion deemed unethical more than 60 academic and community study sites were approached, general response was enrolling patients in the open fusion arm would be unethical given most considered MIS to be the standard of care. Four Studies (2 published, 2 in review) four retrospective comparative cohort studies (medical chart reviews) of open and MIS approaches were a result of this effort. 41 Miller Med Dev Evid Res 2013 Analysis of the postmarket complaints database for the SI Joint Fusion System : A minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption Miller LE, Reckling WC, Block JE. Medical Devices: Evidence & Research. 2013;6: Prospective complaints database 5,319 patients o Apr 2009 Jan 2013 o ~16,000 implants US & Europe; 487 different physicians System has strong safety profile o 3.8% overall complaint rate, nearly all minor o 1.8% revision rate Safety 42

15 MIS SI Joint Fusion is Safe and Effective Criteria Data Sources Safety Low complication rate Low complaint rate Low revision rate Low re-treatment rate Miller 2013 Graham-Smith 2013 Duhon 2013 Cummings 2014 Efficacy Pain improvement ODI improvement QOL improvement SF-12 SF-36 EQ-5D Long-Term Outcomes Graham-Smith 2013 Duhon 2013 Cummings 2014 Rudolf 2012 Rudulf 2013 Sachs 2013 Gaetani Economics Article N Design Results Ackerman Clinicoecon Outcomes Res 2013 Ackerman Clinicoecon Outcomes Res 2014 Ackerman J Neurosurg Spine ,452 78,533 14,552 Medicare Cost comparison: non-op vs. MIS SIJ fusion Commercial Cost of non-op care for SIJ pathology Medicare Cost of non-op care for SIJ pathology MIS fusion provided patient savings over nonop tx ($660 million over patients lifetime) SI joint non-op Tx = high economic burden for Commercial population SI joint non-op Tx = high economic burden for Medicare population 44 The Right Target? Retrospective claims data: Patients diagnosed with SI joint pain within 1 year post-lumbar fusion 7% of Medicare patients 1 17% of Commercial patients 2 Misdiagnosis? Concomitant disease? New SI Joint Disease? 1. Ackerman SJ, et al. Non-Operative Care to Manage Sacroiliac Joint Disruption and Degenerative Sacroiliitis is Costly and Requires High Medical Resource Utilization in the Medicare Population. J Neurosurg Spine Apr;20(4): Epub 2014 Feb Ackerman SJ, et al. Management of sacroiliac joint disruption and degenerative sacroiliitis with nonoperative care is medical resource-intensive and costly in a United States commercial payer population. Clinicoecon Outcomes Res Feb 11;6:

16 MIS SI Joint Coding History Prior to July 1, 2013 Effective July 1, 2013 Effective Jan 1, 2015 Category I CPT code Arthrodesis, sacroiliac joint (including obtaining graft) SIJ fusion was typically reported using this code whether procedure was performed open or MIS. [This code is no longer appropriate for MIS] Category III code 0334T sacroiliac joint stabilization for arthrodesis, percutaneous or minimally invasive (indirect visualization), includes obtaining and applying autograft or allograft (structural or morselized) when performed, includes image guidance when performed. Accepted addition of 2729X with related revision of to differentiate the intent from the new code and deletion of current Category III code 0334T to describe percutaneous/minimally invasive sacroiliac joint arthrodesis. 46 SI Joint Fusion: Summary SI joint is pain generator with relatively high prevalence Correct diagnosis key (thorough SI joint exam, provocative tests, injections) Treatment options o Conservative care little evidence o MIS SIJ Fusion option when conservative care fails SI Joint pathology is a economic burden, cost effective options needed Strong MIS SI joint fusion clinical evidence for safety and efficacy AMA CPT Cat I Code 47 In Conclusion, expect an accelerated pace in spine surgery patterns adjusting to downward pressure impact with Obama Care; MIS Spine will continue to evolve and endoscopy is the future Thank You Express my gratitude to: Linda Simmons, Regional OP of Symbion & Ms. Kelly Hallis, Emerson Consultants (Task Force Committee Member) 48

17 ISASS14 April 30 May 2, 2014 Abstract Submissions Open May 1, 2013